Correction: e3.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, information from the author, and a correction.New information was added to the following fields: b3, b5, h6, h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.
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